1. The Field of the Invention
The present invention is in the field of restorative dentistry. More particularly, the invention is in the field of compositions, methods and kits for hemostasis and sealing of dental pulp and/or dentin during the excavation of deep cavities, preparation for the placement of crowns, and other invasive dental procedures that expose the pulp and/or pink dentin. The compositions, methods and kits employ propylhexedrine as a hemostatic agent together with an adhesive composition to seal and at least partially fill a hollow within a tooth.
2. The Relevant Technology
During invasive dental procedures, such as the excavation of deep cavities or placement of crowns, it is customary to use a cap or liner over the exposed pulp or dentin preparatory to receiving the final filling material. Dental liners may be applied before the application of a filling material to, e.g., act as a barrier against ingress of bacteria, which can cause decay, to stimulate reparative dentin, and/or to provide thermal insulation. Pulp caps are more particularly used when both pink dentin and the pulp are exposed.
Dental liners can be used with virtually any type of filling material, although they are more typically used where the filling material comprises metal amalgam. Since composite fillings typically form a relatively good seal with the dentin and enamel, it is generally not necessary to use dental liners with composite fillings unless the preparation extends into, or is near, a pulpal exposure. Dental liners are, however, generally needed with metal amalgam fillings since metal amalgam fillings typically do not seal the exposed interior of the tooth from accessibility by bacteria. Such liners may also be used to stimulate reparative dentin provide thermal insulation.
The same dental material utilized for liners is also conventionally utilized for pulp capping to protect the pulp after excavating deep caries which result in penetration near or into the pulp chamber. The pulp and the adjacent tissue, the pink dentin, are the living portion of a tooth and accordingly are highly prone to destruction by pathogenic contamination. The failure to properly seal the pulp chamber and pink dentin can lead to bacterial infection of the pulp. Such infections are very difficult for the body to fight and may often lead to serious infections of the teeth and surrounding bone.
Since the pulp and pink dentin are surrounded by hard enamel or filling material, infected dental tissues are incapable of expanding with the inflammation caused by the infection. Thus, tooth infections may lead to circulatory "back pressure" which, in turn, can often restrict blood flow to the infected area. Restriction of the blood supply to the tooth greatly inhibits the ability of the pulp to fight off the infection since needed macrophages and antibodies are inhibited or prevented from entering into the infected area. Infections of the pulp generally cause the tooth to die. Thus, it was generally thought that "exposed pulp is a dumed organ". Accordingly, it is generally crucial when exposing the pulp during an invasive dental procedure to protect the pulp from infection by utilizing a pulp cap as a barrier against the ingress of bacteria and/or to initiate reparative bridge formation for a biological seal.
In addition to sealing the pulp cavity to prevent the ingress of bacteria, it may also be advantageous to stimulate reparative bridge formation. To increase the likelihood of reparative bridge formation, compositions which contain calcium, such as calcium hydroxide, are conventionally utilized since the calcium is believed to be incorporated as hard tooth material by the living pink dentin. Calcium hydroxide compositions may also provide antibacterial activity since the high pH of the calcium hydroxide kills bacteria.
Exposure of the pulp often occurs as a result of excavating deep caries in preparation for placing a filling or crown. Restorative dental procedures related to fillings and crowns may require the use of harsh chemicals which can result in postoperative sensitivity if the chemicals contact the pulp. The steps for restorative dental procedures related to fillings and crowns if a deep preparation or exposure has been excavated, generally involve disinfecting the area with a disinfectant, drying the area, placing a pulp cap at or near the opening into the pulp chamber, etching the area, priming the area and then applying a bonding resin for a composite or crown or placing a metal amalgam filling. Thus, a properly applied pulp cap not only minimizes the likelihood and degree of postoperative sensitivity from chemicals or bacteria in the dentin tubules near or in the pulp, but the postoperative inflammatory response is also reduced, thus promoting healing and predictable nonendodontic success.
Although the survivability of a tooth having an exposed or nearly exposed pulp can be increased by the use of a pulp cap, conventional pulp caps generally fail to adequately seal a treated area and generally have a deleterious impact on the retention of restorations. Moreover, conventional liners may have a negative impact on a bonded restoration due to the generally low strength of the liner, which is significantly less than that of the covering restorative material. Conventional liners can easily become dislodged during placement of the filling material, during shaping of the filling material, or as a result of subsequent jarring or harsh manipulation of the tooth.
In addition to the poor adhesion of some dentin liners and pulp caps, particularly those which include calcium hydroxide, adhesion may further be inhibited due to bleeding and oozing of fluid from the pulp and/or dentinal tubules. Although there are a number of astringents on the market, such as those based on salts of aluminum, iron and zinc, such astringents are not used because they can cause tremendous pain and will generally kill the pulp, thus requiring a root canal. Bleeding and oozing of fluid from the pulp and/or dentinal tubules can also contaminate the dentin liner or pulp cap.
Accordingly, it would be an improvement in the art of restorative dentistry to provide compositions, methods and kits that enabled more reliable sealing and adhesion to the dentinal tissue so as to provide a reliable barrier to the ingress of bacteria into the pulp and/or pink dentin and thereby prevent infection of the tooth.
More specifically, it would be an important improvement in the art of restorative dentistry to provide compositions, methods and kits which could arrest the bleeding of the pulp and/or pink dentin subsequent to exposure of the pulp and/or pink dentin and preparatory to the application of an adhesive sealant or filling material to the dentin.
It would be a further improvement in the art to provide compositions, methods and kits which included a hemostatic agent that was capable of arresting the bleeding of exposed pulp and/or pink dentin which did not result in the death of the pulp.
Finally, it would yet be an improvement in the art to provide compositions, methods and kits which included an adhesive liner, capping and/or filling material capable of forming a strong and reliable seal against the dentin in order to form a reliable barrier against the ingress of microorganisms into the pulp and/or pink dentin.
Such compositions, methods and kits for providing hemostasis of the pulp and/or pink dentine and a strong and reliable seal against the dentin are disclosed and claimed herein.